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Trial registered on ANZCTR


Registration number
ACTRN12616000036415
Ethics application status
Approved
Date submitted
14/01/2016
Date registered
19/01/2016
Date last updated
19/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can supportive text messaging post-detox boost treatment outcomes following inpatient alcohol and other drug withdrawal?
Scientific title
Effectiveness of supportive text messaging after participation in inpatient alcohol/drug withdrawal services on alcohol and drug use and psychological distress.
Secondary ID [1] 288302 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addiction 297263 0
Alcohol problems 297264 0
Drug problems 297265 0
Mental health 297266 0
Condition category
Condition code
Mental Health 297465 297465 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial design will be used for this study. Participants who are randomly to the intervention group will receive supportive text messages twice a day (morning and evening) for 4 weeks after discharge from an inpatient detoxification facility, Participants will also be asked to report their drug and alcohol use each week via text messages.

Text messages:
Supportive text messages include material aimed at relapse prevention; asking for help, changing behaviour, avoiding triggers, managing cravings, increasing self-esteem, helping others, and planning for success. Material was sourced from a variety of sources, including messages used in previous studies, 12-Step programs, the positive affirmation literature and consultation with addiction experts..

Examples of the text messages for the participants in the intervention group are:
“Keep recovery as a priority and you will reach your goals”- Changing behaviour
"What will you do if you find yourself around alcohol unexpectedly? Take some time to develop new strategies to help you cope."- Planning for success
"Practise distraction techniques; do not give in to your cravings."- Managing cravings
"You are powerful and in control of your own future."- Increasing self-esteem
"Spend more time with like-minded, non-drinking peers."- Asking for help
"Try to limit your time spent with friends or family who are heavy drinkers."- Avoiding triggers

Weekly alcohol and other drug use self-report prompts
Each week, participants in the intervention group will also receive a text message prompting them to report their weekly alcohol and other drug consumption via text message. Specifically, every participant who underwent alcohol withdrawal will receive a text asking:
“How many days in the last week did you consume alcohol? Please reply with a number between 0 and 7," and every participant who underwent withdrawal for an illicit drug will receive a text asking:
“How many days in the last week did you use the drug that has caused you the most concern? Please reply with a number between 0 and 7."
Intervention code [1] 293599 0
Treatment: Other
Intervention code [2] 293600 0
Behaviour
Comparator / control treatment
Participants in the control group of this study receive the standard aftercare planned for them, as well as a weekly text message for 4 weeks that prompts them to contact DirectLine if they need assistance: “Hi from the Wellington House SMS study team. We hope you are well, remember If you need assistance, please call DirectLine on 1800 888 236.”

Participants in the control group are also required to report their weekly alcohol and drug use via text message for the 4 weeks that the study runs.
Control group
Active

Outcomes
Primary outcome [1] 297028 0
Changes in the severity of alcohol and/or drug use, as measured by the total score on the Alcohol Use Disorder Identification Test (AUDIT) and the Drug Use Disorder Identification Test (DUDIT) for substance use severity (whichever is appropriate, according to the primary drug of concern identified by participants upon admission to the inpatient detox facility).
Timepoint [1] 297028 0
1. Upon admission to inpatient detox facility (baseline assessment)
2. Four weeks after discharge from inpatient detox facility (follow-up).
Primary outcome [2] 297029 0
Changes in the levels of psychological distress reported by participants, as measured by the The Kessler Psychological Distress Scale (K10).
Timepoint [2] 297029 0
1. Upon admission to inpatient detox facility (baseline assessment)
2. Four weeks after discharge from inpatient detox facility (follow-up).
Primary outcome [3] 297030 0
Changes in the frequency (number of days in the past month) in the consumption of either alcohol or drugs (i.e., the primary drug of concern identified by participants upon admission to the inpatient detox facility, alcohol or drugs) in the four weeks after discharge from Wellington House, as measured by the Timeline Followback (TLFB).
Timepoint [3] 297030 0
1. Four weeks after discharge from inpatient detox facility (follow-up).
Secondary outcome [1] 319882 0
Defining acceptability and satisfaction with the intervention, as measured by a designed-for-purpose qualitative questionnaire.
Timepoint [1] 319882 0
Four weeks after discharge from inpatient detox facility (follow-up assessment).
Secondary outcome [2] 319930 0
**Please note that this is a primary outcome

Changes in the amount of consumption of alcohol or drugs (i.e., the primary drug of concern identified by participants upon admission to the inpatient detox facility, alcohol or drugs) in the four weeks after discharge from Wellington House, as measured by the Timeline Followback (TLFB).
Timepoint [2] 319930 0
1. Four weeks after discharge from inpatient detox facility (follow-up assessment).

Eligibility
Key inclusion criteria
Eligibility criteria for this study are as follows:

1. Participants have a mobile phone with credit, and are not intending to change their number over the next month.
2. Participants are familiar and comfortable with sending and receiving text messages on their mobile phone.
3. To the best of their knowledge, participants will be available the follow-up phone interview with the research team in four weeks time.
4. Participants must have completed detoxification for alcohol and/or drugs at Wellington House.
5. Participants consent to participate in the research, if they are eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria are as follows:
1. Individuals under the age of 18, because their recovery and support needs may be different.
2. Participants who are continuing on to longer term residential rehabilitation programs, where access to technology is limited or prohibited, and use of alcohol and other drugs is prohibited.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation is stratified by primary drug of concern (i.e., alcohol or drugs), and allocation to the intervention or control group will occur on a 1:1 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation based on the reported effect size for differences in percentage days of abstinence in a similar earlier study (Agyapong et al, 2012), indicates a requirement of 30 per condition (a= .05, power=.90). Allowing for attrition (typically 30%) the required sample is 37 per condition. We will aim to recruit 100 patients in total (n=50 per condition) to ensure we have ample power. Given that Wellington House would treat approximately 550 patients in a 15-month interval this should be easily achieved.

Data will be analysed on an intention-to-treat basis using IBM SPSS Statistics 20.0.
Baseline demographic and clinical characteristics of the two groups will be summarised by reporting frequencies (n) with percentages (%) for categorical data and using chi-square to explore group differences and reporting means and standard deviations (SD) or median and interquartile range (IQR) for continuous data. For the outcome data , the statistical significance of observed differences in proportions (e.g. abstinence rates at follow-up) between the intervention and control group will be examined using Pearson chi-squared or Fisher’s exact tests. Continuous data (e.g. number of days of continued abstinence, days of use in the past month, AUDIT, DUDIT scores) will be presented as means (standard deviation) with group comparisons explored using an analysis of covariance (ANCOVA) with the treatment condition (supportive text messages v. no supportive text messages) as the independent variable, and any variable that differs between the groups at baseline e.g K-10 entered as a covariate. Tests will be two-sided with p-values of less than .05 considered significant. Effect sizes (Cohens D) will be calculated between-groups based on the pooled standard deviation of the change in mean scores between baseline and follow-up. For participants with missing data the last observation carried forward (baseline measures) will be used to impute missing data thus attempting to correct for any potential bias caused by missing data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/11/2015
Actual
Date of last participant enrolment
Anticipated
31/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 12535 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 292680 0
Charities/Societies/Foundations
Name [1] 292680 0
Eastern Health Foundation
Country [1] 292680 0
Australia
Primary sponsor type
Other
Name
Turning Point, part of Eastern Health
Address
54-62 Gertrude Street,
Fitzroy, Victoria 3065
Country
Australia
Secondary sponsor category [1] 291400 0
None
Name [1] 291400 0
Address [1] 291400 0
Country [1] 291400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294149 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 294149 0
Office of Research and Research Ethics,
Level 2, 5 Arnold Street,
Box Hill, Victoria, 3128
Ethics committee country [1] 294149 0
Australia
Date submitted for ethics approval [1] 294149 0
01/04/2015
Approval date [1] 294149 0
08/07/2015
Ethics approval number [1] 294149 0
E10-2015

Summary
Brief summary
The project aims to examine whether supportive motivational text messages can serve as ongoing support to reduce relapse rates and extend the duration of continued abstinence among patients recently discharged from in-patient alcohol or other drug (AOD) withdrawal. To achieve this 100 patients who have completed detoxification at
Wellington House will participate in a randomised controlled trial of the intervention (study design).

Patients will be notified by nursing staff that the study is taking place during admission. Those deemed eligibility by the resident doctor will be approached and invited to participate towards the end of their stay. Eligibility criteria are: (i) owning a mobile phone with credit (ii) familiarity with sending and receiving text messages (iii) available for a
telephone follow-up interview 1 month after discharge. If interested the doctor will provide information and oversee the consent taking process if they wish to participate. The consent process will include a request for permission for the researchers to access their screening and assessment data. The resident doctor will complete the client locator form so they can be contacted for a one-month follow-up interview. Once this documentation has been faxed to the research team, the study coordinator at Turning Point (Dr Manning) will take the next sealed envelope which will contains the condition to which the participant is allocated.

Commencing the day after discharge and for the subsequent 4 weeks, the intervention group will receive twice daily motivational SMS and the control group will receive no motivational SMS and only one message a week providing them with the telephone number for Directline should they require support/assistance. Both groups of participants will continue to receive the usual care planned for them prior to discharge from Wellington House for the duration of the study.

Baseline and outcome measures for this project are: (i) The AUDIT and DUDIT for substance use severity and (ii) the K10 to measure psychological distress (from the routinely completed screen and assessment). Additional measures at the one month telephone interview will be the Timeline Followback to establish alcohol and drug use in the past month. The follow-up interview will take approximately 30 mins to complete over the phone with a researcher.

Participants will be sent a weekly SMS asking them to report (via reply SMS) the number of AOD using days for that week.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes
Not applicable

Contacts
Principal investigator
Name 62694 0
Prof Dan Lubman
Address 62694 0
Turning Point
54-62 Gertrude Street,
Fitzroy, Victoria 3065
Country 62694 0
Australia
Phone 62694 0
+61 3 8413 8400
Fax 62694 0
Email 62694 0
[email protected]
Contact person for public queries
Name 62695 0
Victoria Manning
Address 62695 0
Turning Point
54-62 Gertrude Street,
Fitzroy, Victoria, 3065
Country 62695 0
Australia
Phone 62695 0
+61 3 8413 8428
Fax 62695 0
Email 62695 0
[email protected]
Contact person for scientific queries
Name 62696 0
Victoria Manning
Address 62696 0
Turning Point
54-62 Gertrude Street,
Fitzroy, Victoria, 3065
Country 62696 0
Australia
Phone 62696 0
+61 3 8413 8428
Fax 62696 0
Email 62696 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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